MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-07-07 for APPLIANCE,FIXATION,SPINAL INTERLAMINAL manufactured by Synthes Usa.
[49021764]
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Device was used for treatment, not diagnosis. This report is for an unknown synthes cervical spine locking plate (cslp) / unknown quantity / unknown lot. The investigation could not be completed and no conclusions could be drawn, as no device was returned and no lot number or part number was provided.
Patient Sequence No: 1, Text Type: N, H10
[49021765]
Literature article received: this report is being filed after the subsequent review of the following literature article: koehler, s. Et al (2016). Autologous bone graft versus pekk cage for vertebral replacement after 1- or 2- level anterior median corpectomy. Journal of neurosurgery spine, 24, 309-314. Germany. A retrospective comparison of clinical and radiological results of autologous iliac grafts (19 patients) versus those of bone-filled polyetheretherketone (pekk) cage implants (27 patients). The authors retrospectively analyzed the clinical and radiological outcomes of 46 patients (28 male, 18 female, mean age 67 +/- 10 years) with degenerative multilevel cervical stenosis who underwent a 1- or 2-level accf between 2004 and 2012. Of the 46 patients, 19 (mean age 66 +/- 11 years) were treated with autologous bone graft (group 1) while the remaining 27 (mean age 67 +/- 10 years) were treated with polyetheretherketone (pekk) cage implants (non-synthes) (group 2) as vertebral replacement after accf (anterior cervical corpectomy with fusion) of the cervical spine. All of the patients also underwent osteosynthesis with an anterior plate and screw system using a cervical spine locking plate (cslp system, synthes). Mean follow up time was 19. 2 +/- 15. 2 months and 21. 9 +/- 13. 6 months respectively. Of the 27 patients treated the pekk cage and a synthes cervical spine locking plate system, four (4) patients had the following complications: a dislocation of the pekk cage, loosening of the plate-screw system with a new neurological deficit and/or intractable pain. The patients were revised as follows: one patient had an anterior revision of the pekk was necessary after three months. One patient had an anterior revision of the pekk was necessary after four months. One patient had a 2-level corpectomy was extended to a 3-level corpectomy with replacement of the pekk cage by an autologous bone graft and subsequent posterior instrumentation 1 week after the first operation. One patient had an anterior revision procedure followed by posterior instrumentation was performed because of persistent pain and failed bony fusion. This is report 2 of 4 for (b)(4). This report is for an unknown synthes cervical spine locking plate (cslp). This part refers to the following complications: revised due to the dislocation of the pekk cage, loosening of the plate-screw system with a new neurological deficit and/or intractable pain, as well as persistent pain and failed bony fusion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2520274-2016-13373 |
| MDR Report Key | 5777057 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-07-07 |
| Date of Report | 2016-06-22 |
| Date of Event | 2015-10-16 |
| Date Mfgr Received | 2016-06-22 |
| Date Added to Maude | 2016-07-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TERRY CALLAHAN |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | APPLIANCE,FIXATION,SPINAL INTERLAMINAL |
| Product Code | KWO |
| Date Received | 2016-07-07 |
| ID Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES USA |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-07-07 |